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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00500513 |
Primary Objectives:
Condition | Intervention |
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Lung Cancer |
Procedure: CT Scans Procedure: Implanted markers Radiation: Radiation Treatment |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion |
Estimated Enrollment: | 30 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Implanted Markers + CT + Radiation Treatment
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Procedure: CT Scans
CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.
Procedure: Implanted markers
Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope
Radiation: Radiation Treatment
Radiotherapy incorporating respiratory treatment delivery
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If you are eligible to take part in this study, you will have pulmonary (lung) function testing. This testing will involve your breathing through a mouthpiece and measuring the amount of air you breathe. This will provide information on how well your lungs work, and how your chest wall moves when you breathe.
You will then begin the normal treatment planning process. A bean-bag "cast" will be made for you to lie in during planning and treatment. This is done to lower day-to-day changes in your position. A CT scan will be taken with you breathing quietly, and possibly several X-rays will be performed as well. You will be marked with magic marker, and possibly have several permanent tattoos placed to help with daily positioning. These procedures normally take 1-2 hours.
Small metal markers (up to 5) will then be placed near your tumor. A thin, flexible tube with a camera, called a bronchoscope, will be used to place these markers in your lungs. You will be given a sedative through one of your veins and a local anesthetic will be sprayed in your nose and mouth before introducing the bronchoscope. The bronchoscope is introduced through one of your nostrils and then passed into your windpipe and bronchial tubes. This will allow the doctor to examine your lungs and place the small metal markers. These markers will be used to track the tumor during treatment. In this way the radiation treatment can be given to the tumor even if it moves while you breathe.
You will also have studies to measure how much the tumor moves. This will be done with several additional CT scans, typically taken on a weekly basis. You will not be charged for the additional CT scans. Additional pulmonary function measurements will be taken during the CT scans. These measurements will allow researchers to monitor the movement of your tumor when you breathe. These procedures will normally take between 1 and 2 hours.
You will be on this study for the duration of your radiation treatments. You will be followed up an for an additional 4 - 6 weeks to make sure there are no complications from the study.
This is an investigational study. A total of up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient is able to tolerate bronchoscopy:
Exclusion Criteria:
Contact: George Starkschall, PhD | 713-792-3339 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: George Starkschall, PhD |
Principal Investigator: | George Starkschall, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( George Starkschall, PhD/Professor ) |
Study ID Numbers: | ID03-0208 |
Study First Received: | July 10, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00500513 |
Health Authority: | United States: Institutional Review Board |
Lung Cancer Respiratory-Induced Tumor Motion Tumor Motion Pulmonary Function Fiducial Marker |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |